EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee (NCT06895889) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee
36 participantsStarted 2026-01-01
Plain-language summary
EB-OC is a tissue engineered osteochondral tissue graft comprising of a living tissue engineered cartilage layer attaching to a bone scaffold. The goal of this clinical trial is to learn about in the safety and efficacy of the EB-OC graft in participants who require repair of chondral/osteochondral defects of the knee. The main question it aims to answer is if the EB-OC graft works to regenerate osteochondral tissue comprising of native hyaline cartilage anchors to the regenerated bone. Participants will receive treatment of either the EB-OC Graft implantation in an arthrotomy procedure or abrasion chondroplasty. Researchers will compare results from the EB-OC graft to abrasion chondroplasty to assess overall safety and effectiveness.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is male or female, between 18 and 65 years of age
✓. Subject's body mass index (BMI) is ≤ 35 kg/m2.
✓. Subject has up to two symptomatic, full-thickness cartilage defects of the knee femoral condyle with or without bone involvement that are:
✓. Located on the femoral condyles or femoral trochlea
✓. Each between 0.75 and 3 cm2 in area on screening images as confirmed by an independent radiologist
✓. Classified as International Cartilage Repair Society (ICRS) grade 3 or 4.
✓. Has baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain \<65 and KOOS Activities of Daily Life \<70.
✓. Subject is willing and able to provide informed consent and comply with study requirements.
Exclusion criteria
✕. Lesions on the opposing surface of the tibia that are classified as ICRS grade 3 or 4.
What they're measuring
1
Number of adverse event incidents as compared to control
Timeframe: 12 months
2
Adverse event incident rate (% pateint) as compared to control
Timeframe: 12 months
3
Number of adverse events based on electrocardiogram readout as compared to control
Timeframe: Day 1, 1 week post Surgery
4
Incident rate of adverse event (% patient) based on electrocardiogram readout as compared to control
Timeframe: Day 1, 1 week post Surgery
5
Report of all adverse events including incidence, timing, severity, and relationship to the treatment